Walitt + Wolfe: fibromyalgia is overdiagnosed, psychosocial, pharmaceutical scam & quote Shorter


Well-Known Member
Note: I copied this from C-C's list.
The title is not a quote, but a summary of what I take away from the paper
(bolding mine)



Journal of Headache & Pain Management

Fibromyalgia: A Short Commentary
Frederick Wolfe and Brian Walitt

Corresponding author: Brian Walitt
MD, MPH, Georgetown University, Washington, D.C., USA.
Tel: 301-827-0117

Received: September 23, 2016; Accepted: October 05, 2016; Published:
October 15, 2016

Short Commentary

75% of Persons in the General Population Diagnosed with Fibromyalgia
Don’t Have It, But It Is Worse Than That…

In studies of fibromyalgia in 2015 and 2016, we applied fibromyalgia
criteria to the 2012 National Health Interview Survey (NHIS), the
principle source of information on the health of the civilian US
population, and observed that 75% of persons in the US population
reporting a physician diagnosis of fibromyalgia did not satisfy
fibromyalgia criteria [1,2]. Persons with a fibromyalgia diagnosis who
did not report symptoms specific and severe enough to satisfy
diagnostic criteria constitute 1.3% of the US population. We will call
this group criteria-negative fibromyalgia (C- FM). These persons were
nearly exclusively white women (82.2% white, 92.7% women).

Criteria positive fibromyalgia (C+ FM), persons reporting symptoms
severe and specific enough to satisfy fibromyalgia criteria positive
fibromyalgia was prevalent in 1.7% of the US population. The C+ FM
group was much less exclusive, with no ethnic predisposition and a
more modest gender disparity of 2.3:1. However, only 27% of the C+ FM
group also had a physician diagnosis of fibromyalgia [0.5% of US
population]. We will refer to this less common instance when criteria
positivity and physician diagnosis occur together as FM++.

Although the prevalence percentages seem small, the absolute numbers
of people affected by our findings are not. By our calculations almost
3 million people who do not meet fibromyalgia criteria have been given
a fibromyalgia diagnosis. At the other end of the spectrum, there are
almost 3 million persons who satisfy fibromyalgia criteria, but have
not been diagnosed with the disorder by a physician. It appears likely
that many of their physicians when presented with the opportunity to
diagnose fibromyalgia decline to make such a diagnosis. Data such as
these call into question the usual 2-4% population estimates of
fibromyalgia, and the validity of previous epidemiological studies of
fibromyalgia that were not designed to identify physician diagnosis.
We expect that the majority of the subjects considered to have
fibromyalgia in these studies had not been diagnosed as having

Our observations in the NHIS of large numbers, apparently over and
under diagnosed subjects including that C- FM is far better predicted
by demographic factors than symptom reporting, offer essential
insights into the nature of historical and contemporary fibromyalgia.
Whether fibromyalgia is determined by the tender point examination of
the 1990 fibromyalgia criteria or by the symptom assessment tools of
the 2010/2011 criteria [3,4], fibromyalgia assessments are always
subjective; they are influenced by biologic, psychosocial and
environmental factors and, in clinical settings, by the beliefs and
biases of physicians and patients. A C- FM diagnosis of fibromyalgia
can legitimize vague and difficult or distressing symptoms, allowing
entrée into official diagnosis and government approved treatments, or
providing a way toward official disability status. All doctors and
patients have to do is agree on the diagnosis. There is no reliable
way to dispute such a diagnosis, and such a C- FM diagnosis can be
“helpful” to the patient and to the physician who struggles to handle
a difficult problem and sometimes a difficult patient.

The utility of a C- FM or a FM++ diagnosis depends on a general
societal acceptance of fibromyalgia as a “real” disease. Fibromyalgia
is one of a series of contested illnesses whose “nature and existence
are contested as to whether they are primarily mental, psychiatric, or
biological. They are causally undetermined: Their etiology is likewise
contested as to social, genetic, toxic and personal possibilities.”
“They have fuzzy boundaries and are each cross-linked to other
emergent illnesses as subsets, mistaken diagnosis, and comorbid
conditions. They are legally explosive: Each condition is caught up in
court battles, administrative categorization and legislative
maneuvering.” [5]. For patients, there is a battle to establish and
sustain the legitimacy of fibromyalgia, as “society does not readily
grant permission to be ill in the absence of disease” [6].

The current dominant paradigm holds that fibromyalgia is a central
pain disorder in which there is only a small role for psychosocial and
environmental determinants [7,8]. Such a viewpoint is not consistent
with the NHIS results or the long history of expansions and
contractions of similar somatic illnesses. It is wise to remember
George Ehrlich’s admonition: “When one has tuberculosis, one has
tuberculosis, whether or not it is diagnosed. The same is true for
cancer, rheumatoid arthritis, hookworm infestation—really, of the
gamut of diseases but not for fibromyalgia (FM). No one has FM until
it is diagnosed” [9]. One of the implications of Ehrlich’s statement
is that the diagnosis of fibromyalgia is discretionary, and that
patient level psychosocial factors and external societal factors
influence that discretion.

A C- FM diagnosis requires that the physician buy into the
fibromyalgia concept. With C+ FM this buy-in does not occur or is only
partial. Many persons (C+ FM) who satisfied NHIS criteria for
fibromyalgia reported receiving alternative diagnoses, such as
rheumatoid arthritis (15.3%), gout (3.3%), lupus (1.4%), lowback pain
(21.7%), and non-specific “arthritis” (47.5%) [1,2]. The constellation
of severe symptoms can be clinically interpreted and diagnosed in many
different ways, perhaps influenced by clinician and patient beliefs
and their resultant interactions. Published diagnostic criteria appear
to be ignored in C+ FM and used only as a vague guide in determining
what fibromyalgia is in clinical practice (C- FM, FM++).

What these data mean, practically, is that psychosocial and
environmental forces, physician and patient’s beliefs strongly affect
fibromyalgia diagnosis and status. The distinguished medical historian
Edward Shorter characterized fibromyalgia as a “psychic epidemic, an
illness attribution that spreads epidemically, and then is forgotten.”
We have previously noted that the growth of fibromyalgia and its
precursor, fibrositis, began in the 1980s [10], after years of virtual
neglect following the 1904 description of fibrositis [11] and the
veritable shutdown of the fibromyalgia lookalike, neurasthenia, which
was complete by 1930 [12,13]. The neurasthenia shut down followed loss
of societal support with the recognition that neurasthenia was not a
condition of over-sensitive reflexes and was better considered within
a psychological framework [14,15].

Somatic symptoms and syndromes have always existed, but what drives
the modern diagnosis of fibromyalgia?

Three essential stakeholders:
1) The pharmaceutical industry (Pharma);
2) Physicians with intellectual conflicts of interest (COI) and ties to Pharma;
3) Patient support organizations.

In trying to understand why fibromyalgia over diagnosis (C- FM)
exists, we noted that a recent five-year study of health care
utilization in the US military observed an increase in fibromyalgia
prevalence from 0.307% to 0.522% [15]. The authors stated “…we
strongly suspect that the rise in FMS prevalence between 2006 and 2008
is due to drug marketing activities between September 2005 and October
2008, the period when Pfizer “illegally promoted the sale and use of
Lyrica [pregabalin] for a variety of off-label conditions (including
chronic pain) [and] offered and paid illegal remuneration to health
care professionals to induce them to promote and prescribe Lyrica ….”
“By 2008, manufacturers of these drugs began direct consumer marketing
and increased grant monies for FMS provider education and research,
and for FMS advocacy groups …. In 2008, Pfizer provided about $4
million in grants to US physicians, nurses, and other health
professionals to educate them about FMS. Coinciding with these
marketing costs are FMS clinical guidelines developed by consensus and
literature reviews. The 2009 guidelines, based on a meeting funded by
“an independent educational grant from Pfizer,” were developed by US
experts with documented conflicts of interest with manufacturers of
FMS-approved drugs.”

Pfizer-sponsored publications state that “Although awareness and
understanding of FM have improved, it is thought that FM remains
undiagnosed in as many as 3 of 4 people with the disorder (Data on
file. Decision Resources report 2009. Pfizer, New York, NY)” [7,8].
Such articles then point out the presumed medical hazards of delayed
diagnosis and go on to advocate active treatment: “Better health
outcomes and quality of life can be achieved by patients with FM with
effective treatments developed as a result of an enhanced
understanding of the disorder. Clinicians, both individually and in
collaboration with other health care professionals and their patients,
can improve patient care with vigilant recognition and diagnosis of
FM.”—The conclusion of the Pfizer organized and financed
“Fibrocollaborative” with “editorial support” also funded by the
pharmaceutical company [8] while these paragraphs on the extensive
role of Pharma are incomplete; a large literature exists that the
reader may consult [16-20]. The evidence that current medical practice
has led to better health outcomes is non-existent; the general
ineffectiveness of pharmacological therapies outside of the clinical
trial setting has been well characterized by meta-analysis [21,22] and
longitudinal population [23] and insurance database studies [24]. Our
data show that there a millions of potential customers provided more
physicians can be taught to diagnose fibromyalgia, a job that has been
done very well so far by Pharma.

Physician support for fibromyalgia has been a very important force, as
it has driven acceptance of the idea of central pain and a
neurobiological basis of fibromyalgia [25]. However, there is no
evidence that central neurological alteration is the cause of the pain
of fibromyalgia; all findings to date have been derived from
cross-sectional studies unable to determine whether the observed
difference reported represents a risk factor, an epiphenomenon, an
endophenotype, or is causal [26]. Despite the frequent claims that the
rapid pace of neurobiological discovery means that definitive proof is
right around the corner, the prospective studies needed to investigate
fibromyalgia causality still await conception. The single attempt to
prospectively understand the neurobiological mechanisms of “central
pain” disorders was the OPPERA study of temporomandibular disorder
(TMD), which concluded that ‘TMD is a complex disorder with multiple
causes consistent with a biopsychosocial model of illness’ [27].
Failure to demonstrate a reducible neurobiological causality, along
with a host of anomalous observations that are not consistent with
central sensitization [26,28-30], has been willfully ignored or fought
against. It remains hard to find “academic” articles that move beyond
the idea of “central pain” or that consider a strong bio-cultural [31]
or complex systems component to the disorder, although important
publications exist that do this [32].

The role, physicians play in publishing data on fibromyalgia must be
mentioned. Index Medicus now (September 2016) lists 9,366 article
addressing fibromyalgia, and the tangible and intangible benefits
physicians receive from publishing are substantial [18,33]. Why do
independent investigators do fibromyalgia studies? Because it is easy
to find patients and there are always abnormalities. If you look hard
enough almost any questions can seem publishable and justified as an
incremental increase in scientific understanding.

Finally, there has been an enormous and often quite successful effort
by patient support groups to legitimize fibromyalgia and support
fibromyalgia physicians. These efforts have been documented elsewhere
[19,34-36]. For patients and their advocates, the suffering of
fibromyalgia is a self-evident demonstration of legitimacy, even if
the scientific reasons used to establish its medical legitimacy may
not be.

We acknowledge some limitations to the NHIS study. Our data refer
predominantly to the United States. The NHIS data used surrogate
fibromyalgia criteria that we developed and validated. It is likely
actual criteria, had they been available, would led to modestly
different results. In addition, in writing about C- FM, some cases
might include previous FM++ subjects who improved to the extent that
they now longer satisfied criteria. Studies in the clinical literature
suggest this may be a much as 25% of criteria negative subjects.
However, in the NHIS setting that percentage is likely to be lower and
certainly not higher.

In summary, the majority of clinical fibromyalgia cases in the US do
not reach levels of severity considered to be diagnostic. Rather,
fibromyalgia is disproportionally dependent on socially constructed
factors rather than the symptoms themselves.

Diagnostic criteria appear to be used only as a vague guide by
clinicians and patients, allowing for substantial diagnostic expansion
of fibromyalgia.


1 Walitt B, Nahin RL, Katz RS, Bergman MJ, Wolfe F (2015) The
Prevalence and Characteristics of Fibromyalgia in the 2012 National
Health Interview Survey. PLoS One 10: e0138024.

2 Walitt B, Katz RS, Bergman MJ, Wolfe F (2016) Three-Quarters of
Persons in the US Population Reporting a Clinical Diagnosis of
Fibromyalgia Do Not Satisfy Fibromyalgia Criteria: The 2012 National
Health Interview Survey. PLoS One 11: e0157235.

3 Wolfe F, Smythe HA, Yunus MB (1990) The American College of
Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
Report of the Multicenter Criteria Committee. Arthritis Rheum 33:

4 Wolfe F, Clauw D, Fitzcharles MA (2010) The American College of
Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and
Measurement of Symptom Severity. Arthritis Care Res 62: 600-610.

5 Dumit J (2006) Illnesses you have to fight to get: Facts as forces
in uncertain, emergent illnesses. Soc Sci Med 62: 577-590.
6 Nettleton S (2006) ‘I just want permission to be ill’: towards
sociology of medically unexplained symptoms. Soc Sci Med 62:
7 Clauw D, Arnold L, McCarberg B (2011) The science of fibromyalgia.
Mayo Clin Proc 86: 907-911.
8 Arnold L, Clauw D, McCarberg B (2011) Improving the recognition and
diagnosis of fibromyalgia. Mayo Clin Proc 86: 457-464.
9 Ehrlich GE (2003) Pain is real; fibromyalgia isn't. J Rheumatol 30: 1666-1667.
10 Wolfe F, Walitt B (2013) Culture, science and the changing nature
of fibromyalgia. Nat Rev Rheumatol 9: 751-755.

11 Gowers WR (1904) Lumbago: its lessons and analogues. Br Med J 1: 117-121.
12 Taylor RE (2001) Death of neurasthenia and its psychological
reincarnation: A study of neurasthenia at the National Hospital for
the Relief and Cure of the Paralysed and Epileptic, Queen Square,
London, 1870-1932. Br J Psychiatry 179: 550-557.
13 Wessely S (1990) Old wine in new bottles: neurasthenia and "M.E.".
Psychol Med 20: 35-53.
14 Beard GM (1905) A Practical Treatise on Nervous Exhaustion
(Neurasthenia), Its Symptoms, Nature, Sequences, Treatment (5th edn.)
New York: E.B. Treat & Company.
15 Jeffery DD, Bulathsinhala L, Kroc M, Dorris J (2014) Prevalence,
health care utilization, and costs of fibromyalgia, irritable bowel,
and chronic fatigue syndromes in the military health system,
2006-2010. Military Medicine 179: 1021-1029.
16 Moynihan R, Heath I, Henry D (2002) Selling sickness: the
pharmaceutical industry and disease mongering Commentary:
Medicalisation of risk factors. BMJ 324: 886-891.
17 Matheson A (2016) The Disposable Author: How Pharmaceutical
Marketing is Embraced within Medicine's Scholarly Literature. Hastings
Cent Rep 46: 31-37.
18 Fava GA (2016) The Hidden Costs of Financial Conflicts of Interest
in Medicine. Psychother Psychosom 85: 65-70.
19 Barker KK (2011) Listening to Lyrica: contested illnesses and
pharmaceutical determinism. Soc Sci Med 73: 833-842.
20 Reed M, Herrmann M (2012) The Difficulties in Developing and
Implementing Fibromyalgia Guidelines. New Insights into Fibromyalgia.
21 Hauser W, Urrutia G, Tort S, Uceyler N, Walitt B (2013) Serotonin
and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia
syndrome. Cochrane Database Syst Rev 1: CD010292.

22 Uceyler N, Sommer C, Walitt B, Hauser W (2013) Anticonvulsants for
fibromyalgia. Cochrane Database Syst Rev 10: CD010782.

23 Wolfe F, Walitt BT, Katz RS, Lee YC, Michaud KD, et al. (2012)
Longitudinal patterns of analgesic and central acting drug use and
associated effectiveness in fibromyalgia. Eur J Pain 17: 581-586.

24 Kim SC, Landon JE, Lee YC (2015) Patterns of health care
utilization related to initiation of amitriptyline, duloxetine,
gabapentin, or pregabalin in fibromyalgia. Arthritis Res Ther 17: 18.
25 Clauw DJ (2014) Fibromyalgia: a clinical review. JAMA 311: 1547-1555.
26 Walitt B, Ceko M, Gracely JL, Gracely RH (2016) Neuroimaging of
Central Sensitivity Syndromes: Key Insights from the Scientific
Literature. Curr Rheumatol Rev 12: 55-87.

27 Slade GD, Fillingim RB, Sanders AE (2013) Summary of findings from
the OPPERA prospective cohort study of incidence of first-onset
temporomandibular disorder: implications and future directions. J Pain
14: T116-T124.
28 Goffaux P, de Souza JB, Potvin S, Marchand S (2009) Pain relief
through expectation supersedes descending inhibitory deficits in
fibromyalgia patients. Pain 145: 18-23.
29 Potvin S, Paul-Savoie E, Morin M, Bourgault P, Marchand S (2012)
Temporal summation of pain is not amplified in a large proportion of
fibromyalgia patients. Pain Res Treat 2012: 938595.
30 Ceko M, Bushnell MC, Fitzcharles MA, Schweinhardt P (2013)
Fibromyalgia interacts with age to change the brain. Neuroimage Clin
3: 249-260.
31 Morris DB (2000) How to speak postmodern: medicine, illness, and
cultural change. Hastings Cent Rep 30: 7-16.
32 Chapman CR (2010) Painful Multi-Symptom Disorders: A Systems
Perspective. In: Kruger LLA (ed.) Translational Pain Frontiers in
33 Matheson A (2011) How industry uses the ICMJE guidelines to
manipulate authorship‚ and how they should be revised. PLoS Med 8:
34 Brown P, Morello-Frosch R, Zavestoski S (2011) Contested Illnesses:
Citizens, Science, and Health Social Movements. University of
California Press, USA.
35 Barker KK (2008) Electronic support groups, patient-consumers, and
medicalization: the case of contested illness. J Health Soc Behav
36 Conrad P, Barker KK (2010) The Social Construction of Illness Key
Insights and Policy Implications. J Health Soc Behav 51: S67-S79.


Well-Known Member
Without doing a deep read I want to say what is wrong with this guy and why are we putting our trust in him? Maybe I am missing something?

Regarding the NIH study he is part of I guess we don't have a choice. NIH is moving ahead with him.

Get Our Free ME/CFS and FM Blog!

New Threads

Forum Tips

Support Our Work



Shopping on Amazon.com For HR

Latest Resources